Method and device for treating cancer with electrical therapy in conjunction with chemotherapeutic agents and radiation therapy

• US 8,024,048 B2
• Filed: 05/07/2004
• Issued: 09/20/2011
• Est. Priority Date: 03/13/2000
• Status: Expired due to Fees

• Current Assignee: Ionix Medical, Inc.
• Original Assignee: Ionix Medical, Inc.
• Inventors: Kroll, Mark, Kroll, Kai, Schroeppel, Edward
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Bays; Pamela M
• Application Number:
  US10/841,205
• Publication Number:
  US 20050004507A1
• Time in Patent Office: 2,692 Days
• Field of Search: 607/3, 607/75, 607/72, 607/2, 607/50, 607/115, 607/116, 607/142, 607/148, 604/20, 604/27
• US Class Current: 607/72
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

A method for the electrical treatment of malignant tumors and neoplasms by applying a voltage to affected tissue. Devices and various adaptations therein are described for use in electrical therapy. Additionally, various chemotherapeutic agent and radiation therapies are described which may be advantageously used in conjunction with electrical therapy to ameliorate cancer.

Claims

1. A method of treating abnormal tissue growth, comprising:

implanting a first electrode at the site of the abnormal tissue growth;

implanting a generator that functions as a second electrode at a position at least about 5 cm away from the abnormal tissue growth from the abnormal tissue growth;

administering a therapeutic agent having an electrical charge near the second electrode;

applying a first form of electrical therapy at a voltage of between about 3V to 5V between the first and second electrodes in which the second electrode is provided with a polarity similar to the charge of the therapeutic agent and the first electrode is provided with a polarity dissimilar to the charge of the therapeutic agent so that the first form of electrical therapy is effective for causing said therapeutic agent to migrate through bodily tissue to the first electrode implanted at the site of the abnormal tissue growth,

administering a second form of electrical therapy between the first and second electrodes effective for achieving electroporation of cellular membranes, said second form of electrical therapy being delivered at a voltage between about 200 V and about 1300 V;

wherein the first form of electrical therapy is applied for a sufficient amount of time to cause a change in pH of at least about 2 at the site of the abnormal tissue growth.

2. The method of claim 1, further comprising, after applying the first form of electrical therapy, reversing the polarities of the first and second electrodes and applying about 1 V to about 2 V in reverse polarity to disperse the therapeutic agent throughout the abnormal tissue growth.

3. The method of claim 1 wherein said second form of electrical therapy causing electroporation is delivered for an amount of time ranging from 1 μ

s to 1 ms.

4. The method of claim 1 wherein said second form of electrical therapy causing electroporation is delivered a number of times ranging from 10 to 1000 times.

5. The method of claim 1 wherein said second form of electrical therapy causing electroporation is delivered after said first electrical therapy causing attraction of the therapeutic agent to the first electrode.

6. The method of claim 1 wherein said first and second forms of electrical therapy are applied at periods of time that do not overlap.

7. The method of claim 1 wherein said first form of electrical therapy causing attraction of said therapeutic agent to an abnormal tissue growth is delivered for an amount of time ranging from one to four hours.

8. The method of claim 1 wherein during said first form of electrical therapy said first electrode functions as an anode and said second electrode functions as a cathode.

9. The method of claim 1 wherein said therapeutic agent is any of the group consisting of bleomycin, mitoxantrone, melphalan, dactinomycin, doxorubicin, and adriamycin.

10. The method of claim 1 wherein said therapeutic agent is administered by an implantable catheter.

11. The method of claim 1 wherein said second form of electrical therapy causing electroporation is delivered at a duty cycle in the range of 50 to 70 percent.

12. The method of claim 1 wherein said electrical therapy causing attraction of said therapeutic agent to an abnormal tissue growth is delivered at a duty cycle in the range of 50 to 70 percent.

13. The method of claim 1 further comprising administering an adjuvant.

14. The method of claim 1 wherein said abnormal tissue growth is a tumor.

15. The method of claim 1 wherein said abnormal tissue growth is of a prostate.

16. The method of claim 1 wherein said abnormal tissue growth is due to hyperplasia.

17. The method of claim 1 wherein said attraction of said therapeutic agent to an abnormal tissue growth is due to dehydration at an anode and local hydration at a cathode.

18. A method of treating abnormal tissue growth, comprising:

implanting a first electrode at the site of the abnormal tissue growth;

implanting a second electrode at a position at least about 5 em away from the abnormal tissue growth;

implanting a third electrode less than 5 cm away from the abnormal tissue growth;

administering a therapeutic agent near the second electrode;

applying a first form of electrical therapy between the first and second electrodes so that the first electrode has a first polarity and the second electrode has a second, opposite polarity, the first form of electrical therapy effective for attracting said therapeutic agent to the first electrode implanted near the site of the abnormal tissue growth, said first form of electrical therapy being delivered at a voltage of between about 1V and about 5Vi

administering a second form of electrical therapy between the first and third electrodes effective for achieving electroporation of cellular membranes, said second form of electrical therapy being delivered at a voltage between about 200 V and about 1300 Vi and administering a third form of electrical therapy wherein the polarities of the first and second electrodes are reversed and electrical therapy is delivered at about 1 V to about 2 V to disperse the therapeutic agent throughout the abnormal tissue growth, and

administering a fourth form of electrical therapy between the first electrode and the third electrode for a sufficient amount of time to cause a change in pH of at least about 2 at the site of the abnormal tissue growth in order to cause ablation.

19. The method of claim 18 wherein said second form of electrical therapy causing electroporation is delivered for an amount of time ranging from 1 μ

s to 1 ms.

20. The method of claim 19 wherein said second form of electrical therapy causing electroporation is delivered a number of times ranging from 10 to 1000 times.

21. The method of claim 18 wherein said second form of electrical therapy causing electroporation is delivered after said first electrical therapy causing attraction of the therapeutic agent to the first electrode.

22. The method of claim 18 wherein said first and second forms of electrical therapy are applied at periods of time that do not overlap.

23. The method of claim 18 wherein said first form of electrical therapy causing attraction of said therapeutic agent to an abnormal tissue growth is delivered for an amount of time ranging from one to four hours,

24. The method of claim 18 wherein during said first form of electrical therapy said first electrode functions as an anode and said second electrode functions as a cathode.

25. The method of claim 18 wherein said therapeutic agent is any of the group consisting of bleomycin, mitoxantrone, melphalan, dactinomycin, doxorubicin, and adriamycin.

26. The method of claim 18 wherein said therapeutic agent is administered by an implantable catheter.

27. The method of claim 18 wherein said second form of electrical therapy causing electroporation is delivered at a duty cycle in the range of 50 to 70 percent.

28. The method of claim 18 wherein said electrical therapy causing attraction of said therapeutic agent to an abnormal tissue growth is delivered at a duty cycle in the range of 50 to 70 percent.

29. The method of claim 18 further comprising administering an adjuvant.

30. The method of claim 18 wherein said abnormal tissue growth is a tumor.

31. The method of claim 18 wherein said abnormal tissue growth is of a prostate.

32. The method of claim 18 wherein said abnormal tissue growth is due to hyperplasia.

33. A method of treating abnormal tissue growth, comprising:

implanting a first electrode at the site of the abnormal tissue growth;

implanting a generator that functions as a second electrode at a position at a distance from the abnormal tissue growth;

administering a therapeutic agent having an electrical charge near the second electrode;

applying a first form of electrical therapy at a voltage of between about 3V to 5V between the first and second electrodes in which the second electrode is provided with a polarity similar to the charge of the therapeutic agent and the first electrode is provided with a polarity dissimilar to the charge of the therapeutic agent so that the first form of electrical therapy is effective for causing said therapeutic agent to migrate through bodily tissue to the first electrode implanted at the site of the abnormal tissue growth,

administering a second form of electrical therapy between the first and second electrodes effective for achieving electroporation of cellular membranes, said second form of electrical therapy being delivered at a voltage between about 200 V and about 1300 V;

wherein the first form of electrical therapy is applied for a sufficient amount of time to cause a change in pH of at least about 2 at the site of the abnormal tissue growth.

34. The method of claim 33, further comprising, after applying the first form of electrical therapy, reversing the polarities of the first and second electrodes and applying about 1 V to about 2 V in reverse polarity to disperse the therapeutic agent throughout the abnormal tissue growth.

35. The method of claim 33 wherein said second form of electrical therapy causing electroporation is delivered for an amount of time ranging from 1 μ

s to 1 ms.

36. The method of claim 33 wherein said second form of electrical therapy causing electroporation is delivered a number of times ranging from 10 to 1000 times.

37. The method of claim 33 wherein said second form of electrical therapy causing electroporation is delivered after said first electrical therapy causing attraction of the therapeutic agent to the first electrode.

38. The method of claim 37 wherein said first and second forms of electrical therapy are applied at periods of time that do not overlap.